Nucala From GSK

The FDA approved mepolizumab subcutaneous injection (Nucala; GSK) for the add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. The approval carries the limitation that mepolizumab is not indicated for the relief of acute bronchospasm.¹

More than 390 million individuals worldwide are affected by COPD, with symptoms including breathlessness, cough, sputum, and progressive airflow obstruction. Eosinophils are a biomarker for type 2 inflammation and an indicator of the risk of a COPD exacerbation. An estimated 70% of individuals with COPD in the US whose disease is inadequately controlled on inhaled triple therapy (dual long-acting bronchodilators plus inhaled corticosteroid) have a blood eosinophil count (BEC) of 150 cells/μL or higher.²

Pharmacology and Pharmacokinetics

More than 390 million individuals worldwide are affected by COPD, with symptoms including breathlessness, cough, sputum, and progressive airflow obstruction. Eosinophils are a biomarker for type 2 inflammation and an indicator of the risk of a COPD exacerbation. An estimated 70% of individuals with COPD in the US whose disease is inadequately controlled on inhaled triple therapy (dual long-acting bronchodilators plus inhaled corticosteroid) have a blood eosinophil count (BEC) of 150 cells/μL or higher.²

Dosage and Administration

The dose of mepolizumab for the add-on maintenance treatment of adults with inadequately controlled COPD and an eosinophilic phenotype is 100 mg subcutaneously every 4 weeks. The medication should be injected in the abdomen, thigh, or upper arm.¹

Clinical Trials

The efficacy of mepolizumab as add-on maintenance treatment for adults with COPD and an eosinophilic phenotype was evaluated in the double-blind, multicenter, placebo-controlled, randomized trials MATINEE (NCT04133909) and METREX (NCT02105948). In addition to optimal inhaled triple therapy, trial participants were randomly assigned to receive mepolizumab 100 mg or placebo subcutaneously every 4 weeks for 52 to 104 weeks in MATINEE or 52 weeks in METREX. The efficacy population for both trials consisted of patients with a BEC of 150 cells/μL or higher at screening or 300 cells/μL or higher in the previous 12 months.²

The primary end point for both trials was the annualized rate of moderate or severe exacerbations throughout the study. Both trials found a statistically significant reduction in the annualized rate of moderate or severe exacerbations when mepolizumab was added to inhaled triple therapy compared with placebo. In MATINEE, the exacerbation rate per year was 0.80 for the mepolizumab group compared with 1.01 for the placebo group. In METREX, the exacerbation rate per year was 1.40 for the mepolizumab group compared with 1.71 for the placebo group.^1,2

Contraindications, Warnings, and Precautions

Treatment with mepolizumab is contraindicated in patients with a history of hypersensitivity to the medication or any of its components. Hypersensitivity reactions such as anaphylaxis, angioedema, bronchospasm, hypotension, rash, and urticaria have occurred after administration of the medication, which should be discontinued if a reaction occurs.^1,2

Because herpes zoster infections have occurred in patients receiving mepolizumab, vaccination should be considered if medically appropriate. Inhaled or systemic corticosteroids should not be abruptly discontinued when beginning treatment with mepolizumab. If discontinuation of the corticosteroid is appropriate, it should be gradually decreased. Patients with preexisting helminth infections should be treated before starting mepolizumab. If a helminth infection occurs while using mepolizumab and does not respond to antihelminth treatment, mepolizumab should be discontinued until the parasitic infection resolves.^1,2

The most common adverse effects during treatment for COPD are back pain, cough, and diarrhea.¹

REFERENCES

1. Nucala. Prescribing information. GSK LLC; 2025. Accessed May 30, 2025. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Nucala/pdf/NUCALA-PI-PIL-IFU-COMBINED.PDF

2. Nucala (mepolizumab) approved by US FDA for use in adults with chronic obstructive pulmonary disease (COPD). News release. GSK. May 22, 2025. Accessed May 30, 2025. https://us.gsk.com/en-us/media/press-releases/nucala-mepolizumab-approved-by-us-fda-for-use-in-adults-with-chronicobstructive-pulmonary-disease-copd/